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8110 Gatehouse Road, Falls Church, VA 22042

A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)


General Information

Age Group




Protocol Number


Background Information

Refractory melanoma is a type of cancer mainly found on the skin, which may not be responding to available treatments. Researchers have developed a drug called IMO-2125 (sometimes referred to as "study drug"), which may be used to treat refractory melanoma. This is an investigational study, which means the study drug is experimental and is not approved by the U.S. Food and Drug Administration (FDA). The study is being done to compare the effectiveness of the study drug given in combination with ipilimumab (Yervoy®) compared to ipilimumab given alone.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Participants must be 18 years of age or older
  • Histologically confirmed metastatic melanoma with measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), Stage III (lymph node or in transit lesions) or Stage IVA, IVB, or IVC disease that is accessible for injection
  • Confirmed progression during or after treatment with any PD-1
  • Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone or in combination with a MEK inhibitor) or declined targeted therapy
  • Additional eligibility in protocol

Ineligibility Information

  • Ocular melanoma
  • Prior therapy with a TLR agonist, excluding topical agents
  • Active systemic infections requiring antibiotics
  • Known active, hepatitis A, B, or C infection
  • Known diagnosis of human immunodeficiency virus (HIV) infection
  • Women who are pregnant or breast-feeding
  • Impaired cardiac function or clinically significant cardiac disease
  • Additional ineligibility in protocol

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